OCGN 3rd stage emergency approval in India!
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Posted On: 02/02/2021 12:46:20 PM
OCGN 3rd stage
emergency approval in India!
Ocugen Earlier Reported Deal For Commercialization Of COVAXIN In US Market With Bharat Biotech
10:57 am ET February 2, 2021 (Benzinga) Print
Ocugen, Inc., (NASDAQ:OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to fight COVID-19, and Bharat Biotech, a global leader in vaccine innovation, today announced they have entered into a definitive agreement to co-develop, supply, and commercialize Bharat Biotech's COVAXIN™, an advanced stage whole-virion inactivated COVID-19 vaccine candidate, for the United States market.
Under the terms of the agreement, Ocugen will have US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval (including EUA) and commercialization for the US market. Bharat Biotech will supply initial doses to be used in the US upon Ocugen's receipt of an EUA. In addition, Bharat Biotech will support the technology transfer for manufacturing in the US. In consideration for the exclusive license to the US market, Ocugen will share the profits from the sale of COVAXIN™ in the US market with Bharat Biotech, with Ocugen retaining 45% of the profits.
The collaboration will leverage the vaccine expertise of Ocugen's leadership team. In preparation for the development of COVAXIN™ in the US, Ocugen's Vaccine Scientific Advisory Board and Ocugen management have initiated discussions with the U.S. Food & Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA) to develop a regulatory path to EUA and, eventually, biologics license application (BLA) approval in the US market for COVAXIN™. Ocugen is also in active discussions with manufacturers in the US to produce a significant number of doses of COVAXIN™ to support its US immunization program.
"The evaluation of COVAXIN™ has resulted in several unique product characteristics including long-term persistence of immune responses to multiple viral proteins, as opposed to only the spike protein, and has demonstrated broad spectrum neutralizing capability with heterologous SARS-CoV-2 strains, thus potentially reducing or eliminating escape mutants. Requiring only a standard vaccine storage temperature of 2-8oC and with the potential to treat all age-groups, COVAXIN™ may offer an important option to protect lives across America," said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen.
The Central Licensing Authority in India has granted permission for the sale or distribution of COVAXIN™ for restricted use in emergency situations in the public interest, in clinical trial mode. With the kickoff of what is likely to become the biggest national vaccination campaign in India's history, COVAXIN™ is being administered as one of the two COVID-19 shots available under emergency authorization with the first batch of 30 million doses being administered to health professionals and front-line workers.
"The COVID-19 pandemic has affected humanity at large. As a company determined to protect global public health, it has always been important for us to develop vaccines for a global cause. Our goal for all vaccines developed at Bharat Biotech is to provide global access. COVAXIN™ has generated excellent safety data with robust immune responses to multiple viral proteins that persist. With the recent progression of COVAXIN use under EUA in India, I am confident that we will be able to work with Ocugen to develop a plan to bring COVAXIN to the US market.," said Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech.
emergency approval in India!
Ocugen Earlier Reported Deal For Commercialization Of COVAXIN In US Market With Bharat Biotech
10:57 am ET February 2, 2021 (Benzinga) Print
Ocugen, Inc., (NASDAQ:OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to fight COVID-19, and Bharat Biotech, a global leader in vaccine innovation, today announced they have entered into a definitive agreement to co-develop, supply, and commercialize Bharat Biotech's COVAXIN™, an advanced stage whole-virion inactivated COVID-19 vaccine candidate, for the United States market.
Under the terms of the agreement, Ocugen will have US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval (including EUA) and commercialization for the US market. Bharat Biotech will supply initial doses to be used in the US upon Ocugen's receipt of an EUA. In addition, Bharat Biotech will support the technology transfer for manufacturing in the US. In consideration for the exclusive license to the US market, Ocugen will share the profits from the sale of COVAXIN™ in the US market with Bharat Biotech, with Ocugen retaining 45% of the profits.
The collaboration will leverage the vaccine expertise of Ocugen's leadership team. In preparation for the development of COVAXIN™ in the US, Ocugen's Vaccine Scientific Advisory Board and Ocugen management have initiated discussions with the U.S. Food & Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA) to develop a regulatory path to EUA and, eventually, biologics license application (BLA) approval in the US market for COVAXIN™. Ocugen is also in active discussions with manufacturers in the US to produce a significant number of doses of COVAXIN™ to support its US immunization program.
"The evaluation of COVAXIN™ has resulted in several unique product characteristics including long-term persistence of immune responses to multiple viral proteins, as opposed to only the spike protein, and has demonstrated broad spectrum neutralizing capability with heterologous SARS-CoV-2 strains, thus potentially reducing or eliminating escape mutants. Requiring only a standard vaccine storage temperature of 2-8oC and with the potential to treat all age-groups, COVAXIN™ may offer an important option to protect lives across America," said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen.
The Central Licensing Authority in India has granted permission for the sale or distribution of COVAXIN™ for restricted use in emergency situations in the public interest, in clinical trial mode. With the kickoff of what is likely to become the biggest national vaccination campaign in India's history, COVAXIN™ is being administered as one of the two COVID-19 shots available under emergency authorization with the first batch of 30 million doses being administered to health professionals and front-line workers.
"The COVID-19 pandemic has affected humanity at large. As a company determined to protect global public health, it has always been important for us to develop vaccines for a global cause. Our goal for all vaccines developed at Bharat Biotech is to provide global access. COVAXIN™ has generated excellent safety data with robust immune responses to multiple viral proteins that persist. With the recent progression of COVAXIN use under EUA in India, I am confident that we will be able to work with Ocugen to develop a plan to bring COVAXIN to the US market.," said Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech.
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